Savella Should be Banned, Public Citizen Says

<"">Savella (milnacipran) a drug used to treat fibromyalgia, should be banned because it has limited efficacy and carries serious risks, according to the consumer advocacy group, Public Citizen. The group has petitioned the U.S. Food & Drug Administration (FDA) for the Savella ban, pointing out that European regulators refused to approve it as a treatment for fibromyalgia.

According to the Public Citizen petition, in two randomized clinical trials, Savella was found to increase blood pressure, heart rate and suicidal thoughts. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared to 7.2 percent of those on a placebo.

Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.

Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting, Public Citizen said. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation.

Public Citizen also said neither of Savella’s trials showed any statistical effectiveness in treating fibromyalgia beyond three months. And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.

“Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a press release announcing the group’s petition. “The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm.”

Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the “black box” warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults.

In July 2009, the European Medicines Agency rejected Savella’s approval for fibromyalgia, stating that its benefits were “marginal” and “did not outweigh its risks.” This was shortly after the FDA approved the drug in January 2009.

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